Tea's effect on atherosclerosis pilot study

描述(由申请人提供)：茶被广泛认为对健康有好处，特别是对心血管疾病(CVD)。我们小组最近发现，在1900名心肌梗塞住院患者中，每天摄入2杯或更多茶与不喝茶相比，长期死亡率低44%。短期试验支持茶对血管内皮细胞功能的益处，但需要关于茶摄入量对心血管疾病和动脉粥样硬化的长期随机试验，以确定茶的效果。 我们建议对长期饮茶对动脉粥样硬化的影响进行一项原则验证的初步研究。从以医院为基础的大型初级保健实践中，我们将招募30名心血管疾病高危患者并将其随机分配到6个月的时间段，每天饮用3杯茶，作为易溶于冷热液体或水的红茶固体供应。我们将在基线时确认这些固体的多酚含量，并在整个研究过程中使用单一批次的茶叶。在基线和6个月后，我们将使用磁共振成像来评估动脉粥样硬化，这是一种测量动脉斑块大小的准确和可重复性的方法。我们将使用尿儿茶素来测量依从性，尿儿茶素是茶中主要的黄酮类化合物。主要结果将是符合茶的摄入量和2次MRI检查。作为次要结果，我们将测量标准的和新的心血管危险标记物，包括炎症、血栓前状态、纤溶和代谢因子。我们还将使用一种新的亲和柱层析方法来评估饮茶对低密度脂蛋白和极低密度脂蛋白胆固醇氧化性的影响，以及通过内皮功能的血清标记物评估对DNA的氧化损伤和内皮完整性的影响。如果成功，这项先导性研究将为一项更大规模的长期随机试验奠定基础，以确定饮茶对动脉粥样硬化进展的影响。

DESCRIPTION (provided by applicant): Tea is widely thought to have health benefits, particularly on cardiovascular disease (CVD). Our group recently found that intake of 2 or more cups of tea per day was associated with a 44% lower long-term mortality rate than abstention from tea among 1900 patients hospitalized with myocardial infarction. Short-term trials support a benefit of tea on endothelial function, but long-term randomized trials of tea intake on CVD and atherosclerosis are needed to test the effects of tea definitively. We propose a proof-of-principle pilot study of the effect of long-term tea intake on atherosclerosis. From a large hospital-based primary care practice, we will recruit and randomize 30 patients at high risk for CVD to a six-month period of consumption of 3 cups per day of either tea, supplied as black tea solids readily dissolved in hot or cold liquid, or water. We will confirm the polyphenol content of these solids at baseline, and use a single batch of tea throughout the study. At baseline and after 6 months, we will assess aortic atherosclerosis using magnetic resonance imaging, an accurate and reproducible method for measurement of arterial plaque size. We will measure adherence using urinary catechins, the primary flavonoids in tea. The primary outcomes will be compliance with tea intake and 2 MRI examinations. As secondary outcomes, we will measure standard and novel cardiovascular risk markers, including inflammatory, prothrombotic, fibrinolytic, and metabolic factors. We will also assess the effects of tea consumption on oxidizability of LDL and VLDL cholesterol, using a novel affinity-column chromatography approach, on oxidative damage to DNA, and on endothelial integrity, as assessed by serum markers of endothelial function. If successful, this pilot study will form the basis for a larger, long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis.